Exocapsular device and method for lens stabilization

ABSTRACT

A device for implantation into an eye for supporting an intraocular lens during and following surgery. The device may include a ring and at least one support. The ring may have an open portion defined between a first eyelet on a first end and a second eyelet on a second end, the ring being radially compressible. The at least one support may be defined internally of the ring and have a position on which a lens is nestably engaged with the at least one support above a tear in the capsular bag of the eye.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/077,243, filed Nov. 9, 2014, which is herein incorporated byreference in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to a device for implantationinto an eye. More specifically, the present disclosure relates to adevice including a ring and a support for implantation into the ciliarysulcus for stabilizing an artificial IOL lens during and afterintraocular surgery.

BACKGROUND

Various diseases and abnormalities exist that can lead to impairedvision in the human eye. Cataract formation is a leading cause ofreversible blindness in the world. Cataracts are caused by a gradualclouding of the lens over an extended period and may result in completeloss of functional vision.

The human eye includes a compressible lens enveloped by a capsular bag,which is attached to the ciliary muscles by zonules in a 360 degreecircle. Intracapsular cataract extraction involving complete removal ofthe lens, the capsular bag enveloping the lens, and the zonulesconnecting the capsular bag to the scleral wall of the eye was thestandard surgical procedure approximately four decades ago.

Advances in surgery lead to the development of extracapsular cataractextraction, which is performed to remove the cataractous lens whileleaving the capsular bag and zonules substantially intact within theposterior chamber of the eye. In this procedure, a capsulorhexisincision is typically performed to remove a generally circularmid-portion of the anterior capsule of the capsular bag, usually leavingthe posterior capsule, an annular anterior capsular flap and a generallycircular anterior capsulorhexis edge. The cataractous lens is removedfrom the residual capsular bag and replaced with an artificialintraocular lens (IOL). The IOL customarily includes haptics forengaging an inner peripheral surface of the residual capsular bag andcentralize the IOL within the capsular bag.

Those skilled in the art of ophthalmic surgical procedures willappreciate that the capsular bag is a delicate elastic membrane thatenvelops the tens. The capsular bag is connected to the scleral wall ofthe eye through zonule fibers that function to centralize the lensbehind the iris and in alignment with the pupil.

In eye patients with missing or damaged zonules from trauma or disease,the position of the capsular bag within the posterior chamber of the eyeis unstable, making removal of the enclosed cataractous lens difficultand implantation of the IOL challenging.

Rupture of the capsular bag is a relatively common phenomenon even inmodern day cataract surgery, and involves a tear in the anterior capsuleor posterior capsule or both. In absence of capsular support it isdifficult to place an IOL lens in the eye safely. In cases where thereis only a posterior capsular rupture, IOL lenses are routinely placed inthe sulcus over the annular anterior capsule. However in scenarios wherethe annular anterior capsule is also ruptured, this becomes untenable.

When the annular anterior capsule is also ruptured, an IOL is thenimplanted in the anterior chamber of the eye, with the haptics of theIOL being received in the anterior chamber angle region between the irisand the cornea. Alternatively, the IOL can be sutured to the iris orscleral wall in the posterior chamber, with the haptics of the IOLresting between the iris and the ciliary body. In patients that have hada capsulorhexis tear occurring during phacoemulsification, not only isimplantation of the lens more difficult, but the tear and/or missingportion of the capsular bag may allow the IOL to shift or drift into thevitreous of the eye or be decentralized, which would obviously affectvision. The device described herein is particularly adapted to beimplanted in the sulcus of an eye for long-term stabilization of the IOLboth during and after intraocular surgery.

Notwithstanding the advancements made in the prior art in the field ofalternative lenses, there remains a need fur an implant which improvesstabilization of the intraocular environment during and afterintraocular surgery Further, a need exists for a device which enablesprecise and stable implantation of the IOL, lens in the sulcus in spiteof a torn capsule, while minimizing the chance of repositioning overtime. The ciliary sulcus is amore desirable position for lens implant ascompared to the anterior chamber or sclera sutured IOL lenses due to theminimal rate of long term complications.

Hence there is need to provide an implant that provides long-termintraocular lens centration and stabilization in patients having moresignificant capsular tears. Disclosed herein are one or more devices andmethods that advantageously address these issues.

SUMMARY

This summary is provided to introduce in a simplified form concepts thatare further described in the following detailed descriptions. Thissummary is not intended to identify key features or essential featuresof the claimed subject matter, nor is it to be construed as limiting thescope of the claimed subject matter.

According to at least one embodiment, a device for implantation into aneye is provided. The device includes a ring and at least one supportdefined internally of the ring.

According to one or more embodiments, the ring includes an open portiondefined between a first eyelet on a first end and a second eyelet on asecond end. Further, the ring is radially compressible.

According to one or more embodiments, the ring includes an open portiondefined between a first eyelet on a first end and a second end. Further,the ring is radially compressible.

According to one or more embodiments, the at least one support has aposition on which a lens is nestably engaged with the at least onesupport above a tear in the capsular bag of the eye.

According to one or more embodiments, the at least one support defines afirst edge engaged with the second end of the ring and extendingcentrally within the ring to a second edge including a second eyelet.

According to one or more embodiments, the device is made ofbiocompatible material. In some embodiments, the biocompatibie materialis polymetheylmethacrylate.

According to one or more embodiments, the at least one support is afirst spoke defining a first edge engaged with the ring and extendingcentrally within the ring to a second edge.

According to one or more embodiments, the first spoke is positionedsubstantially parallel to the plane formed by the circumference of thering.

According to one or more embodiments, the first spoke is positioned atan angle relative to the plane formed by the circumference of the ring.

According to one or more embodiments, the device further includes asecond spoke positioned approximately 180 degrees from the first spokealong the circumference of the ring and extending centrally.

According to one or more embodiments, the device further includes aplurality of spokes positioned along the circumference of the ring andextending centrally.

According to one or more embodiments, the second edge of the first spokeis engaged with a central point of a segment positioned perpendicular tothe first spoke.

According to one or more embodiments, the at least one support is achord engaged with, and extending between, a third end and a fourth endof the ring.

According to one or more embodiments, the chord is substantiallystraight and wherein the engagement of the chord and the ring at thethird end and fourth end is curved, thereby minimizing risk of furtherdamage to the eye.

According to one or more embodiments, the chord is arced, curved orundulating.

According to one or more embodiments, the chord is positionedsubstantially parallel to the plane formed by the circumference of thering.

According to one or more embodiments, at least a portion of the chord ispositioned outside of the plane formed by the circumference of the ring.

According to at least one embodiment, a method of implanting a deviceinto an eye is provided. The method includes providing an embodiment ofthe device, as described herein. The method further includes implantingthe device into the ciliary sulcus between the iris and the capsular bagof the eye, the device positioned anterior to a tear in the capsular bagof the eye. The method additionally includes positioning the at leastone support proximal to the tear, thereby providing stabilization andcentralization to a lens implanted into the eye thereafter.

According to one or more embodiments, the ring of the device is engagedwith an interior peripheral surface of the ciliary sulcus.

According to one or more embodiments, the method further includesplacing a lens in the ciliary sulcus anterior to, and engaged with, theat least one support.

According to one or more embodiments, the lens is an intraocular lensincluding at least two haptics engaged with an interior peripheralsurface of the ciliary sulcus.

According to one or more embodiments, the step of implanting isperformed by inserting the device through an incision created byphacoemulsification cataract surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

The previous summary and the following detailed descriptions are to beread in view of the drawings, which illustrate particular exemplaryembodiments and features as briefly described below. The summary anddetailed descriptions, however, are not limited to only thoseembodiments and features explicitly illustrated.

FIG. 1 is cross-section view of the human eye.

FIG. 2 is top view of the device including a spoke implanted in an eyeaccording to one or more embodiments of the present invention.

FIG. 3 is a side view of the device including a spoke according to oneor more embodiments of the present invention.

FIG. 4 is a top view of the device including a chord implanted in an eyeaccording to one or more embodiments of the present invention.

FIG. 5 is a top view of the device including a spoke implanted in an eyeaccording to one or more embodiments of the present invention.

FIG. 6 is a flow chart illustrating the method of implanting the deviceinto an eye according to one or more embodiments of the presentinvention.

DETAILED DESCRIPTIONS

These descriptions are presented with sufficient details to provide anunderstanding of one or more particular embodiments of broader inventivesubject matters. These descriptions expound upon and exemplifyparticular features of those particular embodiments without limiting theinventive subject matters to the explicitly described embodiments andfeatures. Considerations in view of these descriptions will likely giverise to additional and similar embodiments and features withoutdeparting from the scope of the inventive subject matters. Although theterm “step” may be expressly used or implied relating to features ofprocesses or methods, no implication is made of any particular order orsequence among such expressed or implied steps unless an order orsequence is explicitly stated.

Any dimensions expressed or implied in the drawings and thesedescriptions are provided for exemplary purposes. Thus, not allembodiments within the scope of the drawings and these descriptions aremade according to such exemplary dimensions. The drawings are not madenecessarily to scale. Thus, not all embodiments within the scope of thedrawings and these descriptions are made according to the apparent scaleof the drawings with regard to relative dimensions in the drawings.However, for each drawing, at least one embodiment is made according tothe apparent relative scale of the drawing.

Referring generally to FIG. 1, the present relates to a device forimplantation into an eye 100. In a normal human eye 100, as depicted inFIG. 1, the lens 1 is enveloped in the capsular bag 2 which ispositioned centrally in the posterior chamber 3 of the eye 100 behindthe iris 5 and aligned with the pupil 6. The capsular bag 2 is anelastic membrane or pouch having a generally circular cross-section, andis attached to the ciliary body 7 of the eye 100 through a series ofzonules 8. The ciliary body 7 is attached to the sacral wall of the eye100. The zonules 8 are thin fibers that function to centralize thecapsular bag 2 and its enveloped lens 1 in a normal anatomic positionwithin the posterior chamber 3 of the eye 100.

In patients suffering from a tear in the CCC (continuous curvilinearcapsulorhexis) during cataract surgery, as illustrated by the tear 50 inFIGS. 2, 4 and 5, the CCC may become unstable and unable to support theintraocular lens (IOL) 44 in the ciliary sulcus 9 or posterior chamber 3of the eye 100 since the tear(s) 50 extend to the posterior portion ofthe capsular bag 2 as well. The missing portion 52 of the capsular bag 2may allow the IOL 44 to shift or drift into the vitreous humour of theeye 100 or be decentralized, thereby resulting in general decentrationof the lens 44 and an unstable intraocular environment.

As is shown in FIGS. 2, 4 and 5, the device 10 of the present inventionmay be adapted to be implanted in the sulcus 9 fur long-termstabilization of the KA, 44 during and after intraocular surgery. Thecapsular bag 2 of FIG. 1 is fully intact and envelopes the lens 1 of theeye 100, but following intraocular surgery to remove a cataractous lens,only a residual capsular bag 2 remains. As discussed supra, a capsulartear 50, as depicted in FIGS. 2 and 4, is a common occurrence duringcataract surgery, causing the bag 2 to become unstable and unfit forimplantation of a lens 44.

During the capsulorhexis surgical procedure, an incision is made in theanterior portion 56 of the capsular bag 2 to remove a generally circularmid-portion 60 of the anterior portion 56 of the capsular bag 26.Following this procedure, the residual capsular bag 2 includes aposterior portion 58, an annular capsular flap on the anterior portion56, and a generally circular capsutorhexis edge 54. During anuncomplicated cataract surgery, the residual capsular bag 12 is able tosupport an artificial intraocular lens (IOL) 44. In situations where theCCC (continuous curvilinear capsulorhexis) tears, however, such as isdepicted in FIGS. 2 and 4, the surgeon is unable to place the IOL 44 inthe sulcus 9 or in the bag 2. The present invention is particularlysuited to aid the surgeon in such situations.

FIGS. 2 and 4 depicts a device 10 for implantation into an eye 100according to at least one embodiment of this invention. The device mayinclude a ring 12 and at least one support 24 defined internally of thering 12. The ring 12 may include an open portion 14 defined between afirst eyelet 16 on a first end 20 and a second eyelet 18 on a second end22. Alternatively, as depicted in FIG. 5, the ring 12 may include anopen portion 14 defined between a first eyelet 16 on a first end 20 anda second end 22. The eyelets 16, 18 may be used to position the device10 within the eye 100 using, for example, a bent-tip instrument.

Further, the ring 12 may be radially compressible, such that the openportion 14 between the two eyelets 16, 18, or between the first eyelet16 and the second end 22, may be expanded and contracted when pressureis applied to the circumference of the ring 12.

By defining a ring 12 including an open portion 14, the device 10 isspecifically adapted to be implanted into the sulcus 9 of the eye 100.More particularly, the device 10 may be positioned between the iris 5and the torn flap of the anterior portion 56 of the capsular bag 2 toengage an inner peripheral surface of the sulcus 9 and to abut against apredetermined diameter of the sulcus 9 (see FIGS. 2, 4 and 5). Further,the support 24 may have a position on which a lens 44 may be nestablyengaged with the at least one support 24 above a tear 50 in the capsularbag 2 of the eye 100, thereby providing support to the IOL 44 bothduring and following intraocular surgery.

As mentioned supra, the ring 12 is generally flexible to resistcompression in a radial direction within the sulcus 9. In oneembodiment, the ring 12 has an unflexed diameter of about 12 mm and aradially inward flexed diameter of about 10 mm. As one skilled in the atwould appreciate, the unflexed and flexed diameter may vary greatlywithout departing from the spirit or scope of the present invention, Thering's compressibility permits, inter alia, placement in the sulcus 9such that the ring 12 engages the inner periphery of the sulcus 9.

FIG. 2 illustrates one or more embodiments of the invention wherein theat least one support 24 is a first spoke 26 defining a first edge 30engaged with the ring 12 and extending centrally within the ring 12 to asecond edge 32. In some embodiments, the device 10 may further include asecond spoke 26 positioned approximately 180 degrees from the firstspoke 26 along the circumference of the ring 12, with both spokes 26extending centrally. Alternatively, the device 10 may include aplurality of spokes 26 positioned along the circumference of the ring12, with each of the spokes 26 extending centrally. The use of a twospokes 26 or a plurality of spokes 26 may be particularly useful incases of severe tears 50 of capsular bag 2 where larger portions (e.g.,greater than 90 degrees) of the CCC are compromised. The additionalspokes 26 offer greater stabilization and centralization to the IOL 44positioned in the sulcus 9.

According to one or more embodiments, any of the spokes 26 may bepositioned substantially parallel to a plane formed by the circumferenceof the ring 12. In some embodiments, as depicted in FIG. 3, the firstspoke 26 may be positioned at an angle relative to the plane formed bythe circumference of the ring 12. The angle may be between 10 and 20degrees, less than 10 degrees, or greater than 20 degrees. By anglingthe spoke 26 anteriorly, greater support may be offered to the IOL 44 bycounteracting the pressure of the IOL 44 after positioning, therebyminimizing the risk of the IOL 44 dislocating in the future.

In one or more embodiments, the second edge 32 of the first spoke 26 isengaged with a central point of a segment 34 positioned perpendicular tothe first spoke 26, thereby forming a “T” shape using the spoke 26 andthe segment 34. The additional segment 34 advantageously offers greatersupport and stability to the lens 44 during and after surgery. someembodiments, the segment 34 may be positioned in a plane parallel to theplane formed by the circumference of the ring 12. Any of the spokes 26and segments 34 described herein may have a length, a width, and ashape. In some embodiments the length is between 3 mm and 6 mm, while inother embodiments the length is approximately 4.5 mm. In someembodiments the width is approximately 0.5 mm. The shape may berectangular, triangular, tubular, or arced, As one skilled in the artwould appreciate, the length, the width and the shape may vary widelywithout departing from the spirit or scope of the present invention.Further, the width, length and shape may be vary in relation to thenumber and position of spokes 26 and segments 34.

FIG. 4 depicts the device 10 including a ring 12 and at least onesupport 24, wherein the at least one support 24 is a chord 36 engagedwith, and extending between, a third end 40 and a fourth end 42 of thering 12. In other words, the ring 12 may extend circumferentially fromthe first end 20 to the second end 22, except that the chord 36 disruptsthe circumferential nature of the ring 12 at a third end 40 and fourthend 42; instead the chord 36 extends within the circumference of thering 12. The chord 36 may be substantially straight, arced, curved, orundulating. Further the engagement of the chord 36 and the ring 12 atthe third end 40 and fourth end 42 may be curved, thereby minimizingrisk of further damage to the eye 100 during insertion and whilepositioned therein.

As with the spoke embodiments, the device 10 including a chord 36 may bepositioned such that the chord 36 extends across the tear 50 and/or themissing portion 52 of the capsular bag 2, thereby offering greaterstabilization and centralization to the IOL 44 positioned in the sulcus9. Also, as with the spoke embodiments, the chord embodiments of thedevice 10 may vary in length, width and shape. In one embodiment thewidth of the chord 36 is 0.5 mm. In some embodiments the chord 36 may bepositioned substantially parallel to a plane formed by the circumferenceof the ring 12. In alternative embodiments, at least a portion of thechord 36 may be positioned outside of the plane formed by thecircumference of the ring 12. For example, an arced or undulating chord36 may have portions positioned outside of the ring's circumferentialplane or may be positioned wholly within the ring's circumferentialplane.

FIG. 5 illustrates a device 10 for implantation into an eye 100including a ring having an open portion 14 defined between a firsteyelet 16 on a first end 20 and a second end 22. In such an embodiment,the at least one support 24 may define a first edge 30 engaged with thesecond end 22 of the ring 12 and extending centrally within the ring 12to a second edge 32 including a second eyelet 18. The device 10 depictedin FIG. 5, according to alternative embodiments, may also include anynumber of spokes 26 or chords 36, as described supra.

In one or more embodiments, the device 10, and/or some or all of itscomponents, may be made of biocompatible material. In some embodiments,the biocompatible material is polymethylmethacrylate (PMMA), althoughthose skilled in the art will appreciate that other biocompatiblematerials suitable for implantation in a sulcus 9 are also available.

FIG. 6 illustrates a method of implanting a device 10 into an eye 100.The method includes, in step 601, providing a device 10 according to anyof the embodiments described herein. Further, the method may include, instep 602, implanting the device 10 into the ciliary sulcus 9 between theiris 5 and the capsular bag 2 of the eye 100. Implanting may beperformed by inserting the device 10 through an incision created byphacoemulsification cataract surgery, as described supra. The incisionmay be 1 mm in length, but may also be slightly smaller or much larger.

The method may further include, in step 603, positioning the at leastone support 24 proximal to the tear 50, thereby providing stabilizationand centralization to a lens 44 implanted into the eye 100 thereafter.The device 10 may be positioned anterior to a tear 50 in the capsularbag 2 of the eye 100. Further, the device 10 may be positioned in acircumferential manner within the sulcus 9 such that at least onesupport 24 is positioned proximal to the tear 50 and/or missing portion52 of the capsular bag 2. The ring 12 of the device 10 may be engagedwith an interior peripheral surface of the ciliary sulcus 9.

Following implantation of the device 10 into the ciliary sulcus 9, themethod may further include, in step 604, placing a tens 44 in theciliary sulcus 9 anterior to, and engaged with, the at least one support24. The lens 44 may be an intraocular lens (IOL) including at least twohaptics 46 engaged with an interior peripheral surface of the ciliarysulcus 9. The placement of the IOL 44 may include placing the haptics 46in a position proximal to the portions of the capsular bag 2 which arenot tom 50 or missing 52.

1. A device for implantation into an eye, comprising: a ring having anopen portion defined between a first end and a second end, the ringbeing radially compressible; at least one support defined internally ofthe ring and having a position for nestably engaging a lens, the atleast one support being positioned above a tear in the capsular bag ofthe eye.
 2. The device of claim 1, wherein the device is made ofbiocompatible material.
 3. The device of claim 2, wherein thebiocompatible material is polymetheylmethacrylate.
 4. The device ofclaim 1, wherein: the at least one support is a first spoke defining afirst edge engaged with the ring and extending centrally within the ringto a second edge; and the ring further includes a first eyelet on thefirst end and a second eyelet on the second end.
 5. The device of claim4, wherein the first spoke is positioned substantially parallel to aplane formed by the circumference of the ring.
 6. The device of claim 4,wherein the first spoke is positioned at an angle relative to a planeformed by the circumference of the ring.
 7. The device of claim 4,further comprising at least a second spoke positioned along thecircumference of the ring and extending centrally.
 8. The device ofclaim 4, wherein the second edge of the first spoke is engaged with acentral point of a segment positioned perpendicular to the first spoke.9. The device of claim 1, wherein: the at least one support is a chordengaged with, and extending between, a third end and a fourth end of thering; and the ring further includes a first eyelet on the first end anda second eyelet on the second end.
 10. The device of claim 9, whereinthe chord is substantially straight and wherein the engagement of thechord and the ring at the third end and fourth end is curved, therebyminimizing risk of further damage to the eye.
 11. The device of claim 9,wherein the chord is arced, curved or undulating.
 12. The device ofclaim 9, wherein the chord is positioned substantially parallel to aplane formed by the circumference of the ring.
 13. The device of claim9, wherein at least a portion of the chord is positioned outside of aplane formed by the circumference of the ring.
 14. The device of claim1, wherein: the ring further includes a first eyelet on the first end;the at least one support defines a first edge engaged with the secondend of the ring and extending centrally within the ring to a second edgeincluding a second eyelet.
 15. A method of implanting a device into aneye, comprising: providing a device including: a ring having an openportion defined between a first end and a second end, the ring beingradially compressible; a first eyelet and a second eyelet; and at leastone support defined internally of the ring; implanting the device intothe ciliary sulcus between the iris and the capsular bag of the eye, thedevice positioned anterior to a tear in the capsular bag of the eye;positioning the at least one support proximal to the tear, therebyproviding stabilization and centralization to a lens implanted into theeye thereafter.
 16. The method of claim 15, wherein the ring of thedevice is engaged with an interior peripheral surface of the ciliarysulcus.
 17. The method of claim 15, wherein the step of implanting isperformed by inserting the device through an incision created byphacoemulsification cataract surgery.
 18. The method of claim 15,further comprising placing a lens in the ciliary sulcus anterior to, andengaged with, the at least one support.
 19. The method of claim 18,wherein the lens is an intraocular lens including at least two hapticsengaged with an interior peripheral surface of the ciliary sulcus. 20.The method of claim 15, further comprising positioning the device withinthe eye using the eyelets.